510(k) Report

Devices descending from K121762

21 later devices reach Cardiac VX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140587MR-CT VvaMedis Medical Imaging Systems BV201519—
+1K130228SuiteheartNeosoft, LLC20130—
+2K260811Heartvue.ProtonHeartvue.ai, Inc.20260—
+2K191125ADAS 3DGalgo Medical S.L20205—
+2K181825CAAS MR SolutionsPie Medical Imaging BV20181—
+2K181892Ziostation2Ziosoft, Inc.20181—
+2K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.20180—
+2K163253Arterys Cardio DLArterys, Inc.20174—
+2K162513Arterys Software v2.0Arterys, Inc.20165—
+2K162112Caas MRVPie Medical Imaging BV20162—
+3K232007CAAS MR SolutionsPie Medical Imaging BV20240—
+3K210850ADAS 3DAdas3D Medical S.L.20214—
+3K200315Ziostation2Ziosoft, Inc.20200—
+3K182034Arterys MICAArterys, Inc.20183—
+4K212421ADAS 3DAdas3D Medical S.L.20213—
+4K192437Arterys MICAArterys, Inc.20202—
+5K230803ADAS 3DAdas3D Medical S.L.20232—
+5K203744Arterys MICAArterys, Inc.20221—
+6K252539Tempus PixelArterys, Inc.20250—
+6K240791ADAS 3DAdas3D Medical S.L.20241—
+7K253969ADAS 3DAdas3D Medical S.L.20260—